Stem Cell TransplantationImMiGeNeNCT02940093
Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers
An observational study of Stem Cell Transplantation, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Stem Cell Transplantation
- What is being tested?
- Stem cell transplantation
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 24 Nov 2016to Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Patients undergoing stem cell transplantation due to hematological malignancies Allogeneic stem cell donors
Who may be able to join
- Patient (stem cell recipient) with hematological malignancies, age 3-18
- Healthy allogeneic stem cell donor (identical or non-identical related donor)
Who cannot join
- Patients <3 years of age
- Patient who are unable to provide urine, stool or blood samples due to their medical condition
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Children's Hospital Tübingen
Tübingen, 72076
Peter Lang, MD, 07071 ext. 83781, Peter.Lang@med.uni-tuebingen.de
About this study
Official title: Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management
The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.
- Conditions
- Stem Cell Transplantation
- Being tested
- Stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell transplantationOther
Intervention is not conducted as part of the study but patients at Tübingen University Hospital undergoing this intervention as part of their standard care are being monitored in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| Stem cell transplant recipient | Not described Receives: Other: Stem cell transplantation | |
| Stem cell donor | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.
Measured: through study completion, anticipated after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2016 (estimated)
- Study start24 Nov 2016
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stem Cell TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alexander NR Weber, PhD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02940093
- Sponsor's protocol ID
- ImMiGeNe-001
- Acronym
- ImMiGeNe
- Status last verified
- Nov 2017
- First submitted
- 13 Oct 2016
- Last updated
- 14 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Pipeline Integrating Gut Metagenome Data, Host Immunogenetic Characteristics and Clinical Gut Inflammatory Biomarkers for Stratified Clinical Management
- ClinicalTrials.gov ID
- NCT02940093
- Acronym / sponsor ID
- ImMiGeNe / ImMiGeNe-001
- Conditions
- Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 20 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The combined analysis of microbiome, immunological parameters and host genetics in patients has potential for applying personalized approaches of prevention, diagnostics or therapy in the future. However, the acquisition and analysis of these patient characteristics in a scientifically sound, technically reliable, cost-effective, practicable and future-oriented fashion are a far from trivial task. Therefore the objectives of the study are (i) to optimize a sample and data acquisition and analysis pipeline that fulfills these criteria (using samples from healthy volunteers); (ii) validate the pipeline in a cohort of children undergoing stem cell transplantation, yielding information on host immuno-genetics, gut immune function and the human gut microbiome; (iii) deduct the most critical parameters for host-microbiome interplay from this complex dataset.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stem cell transplant recipient | – | Other: Stem cell transplantation |
| Stem cell donor | – | – |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Patients undergoing stem cell transplantation due to hematological malignancies Allogeneic stem cell donors
Key inclusion criteria (2 listed)
- Patient (stem cell recipient) with hematological malignancies, age 3-18
- Healthy allogeneic stem cell donor (identical or non-identical related donor)
Key exclusion criteria (2 listed)
- Patients <3 years of age
- Patient who are unable to provide urine, stool or blood samples due to their medical condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cell transplantationIntervention is not conducted as part of the study but patients at Tübingen University Hospital undergoing this intervention as part of their standard care are being monitored in this observational study. | Other | Stem cell transplant recipient |
Primary outcome
Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively.
Time frame: through study completion, anticipated after 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander NR Weber, PhD principal investigator
University Hospital Tuebingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stem Cell Transplantation, run by University Hospital Tuebingen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander NR Weber, PhD (+49 7071 29 ext. 87623, alexander.weber@uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immune system - intestinal microbiota co-re-emergence after myeloablative conditioning and antibiotics treatment, respectively. (time frame: through study completion, anticipated after 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.